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A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease After at Least 2 Lines of Systemic Therapy

This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).

开始日期2024-07-30

申办/合作机构

Incyte Biosciences Japan GK

NCT05068466 / Completed临床1期

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants

This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.

开始日期2021-10-21

申办/合作机构

Incyte Biosciences Japan GK

NCT04674748 / Terminated临床1期

A Phase 1 Study Exploring the Safety, Tolerability, and Pharmacokinetics of INCB086550 in Japanese Participants With Advanced Solid Tumors

This study will assess the safety, tolerability, and PK of INCB086550 and determine the Maximum Tolerated Dose (MTD) and/or recommended Phase 2 Dose(RP2D) of INCB086550, whichever is lower, in Japanese participants with advanced solid tumors.

开始日期2021-02-03

申办/合作机构

Incyte Biosciences Japan GK

100 项与 Incyte Biosciences Japan GK 相关的临床结果

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0 项与 Incyte Biosciences Japan GK 相关的专利（医药）

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3

项与 Incyte Biosciences Japan GK 相关的文献（医药）

2024-04-01·Cancer Medicine

PD‐1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study

Article

作者: Koyama, Takafumi ; Yoh, Kiyotaka ; Yamamoto, Noboru ; Mita, Tetsuya ; Yonemori, Kan ; Shimizu, Toshio ; Kuboki, Yasutoshi ; Harano, Kenichi ; Matsubara, Nobuaki ; Chen, Xuejun ; Gu, Yuan ; Ueda, Eiji ; Doi, Toshihiko ; Naito, Yoichi ; Kondo, Shunsuke

AbstractBackgroundRetifanlimab is a humanized monoclonal antibody targeting programmed death protein‐1, and INCB001158 is an oral arginase inhibitor. This phase Ib study investigated retifanlimab, INCB001158, and their combination in Japanese patients with advanced solid tumors.MethodsPatients received retifanlimab (500 mg every 4 weeks [Q4W] i.v.) or escalating doses of INCB001158 (75 or 100 mg twice daily [BID]) monotherapy in Part 1 and combination of retifanlimab (500 mg Q4W) and INCB001158 (100 mg BID) in Part 2. Primary endpoints were safety, tolerability, dose‐limiting toxicities (DLTs), and determination of recommended phase II doses in Japanese patients.ResultsEighteen patients (retifanlimab or INCB001158 monotherapy and combination; n = 6 each) were enrolled at 2 sites in Japan. There were no DLTs, fatal adverse events (AEs), or discontinuations due to AEs. Rash (all grade 1) was the most common treatment‐emergent AE with retifanlimab (n = 6). Treatment‐related AEs were reported with retifanlimab (n = 4) or INCB001158 (n = 2) monotherapy and with combination (n = 4); an immune‐related AE (thyroid disorder, grade 2) was reported with combination. Two responses were observed with retifanlimab monotherapy (1 complete, 1 partial) and 1 stable disease (SD), for an overall response rate of 33.3% (95% confidence interval [CI], 4.3–77.7) and disease control rate (DCR) of 50% (95% CI, 11.8–88.2). Three patients had SD with INCB001158 monotherapy (DCR 50%; 95% CI, 11.8–88.2). No responses or SD were observed with combination therapy.ConclusionRetifanlimab, INCB001158, and their combination had acceptable safety profiles. Promising retifanlimab antitumor activity warrants further investigation in Japanese patients.

2021-01-01·Folia Pharmacologica Japonica

Pharmacological characteristics and clinical study results of Pemigatinib (Pemazyre<sup>®</sup> Tablets), a selective fibroblast growth factor receptor (FGFR) inhibitor

Article

作者: Kabu, Koki ; Takei, Satoko ; Harada, Takashi ; Kitazawa, Kazuya ; Kondo, Midori

Pemigatinib (Pemazyre^® Tablets 4.5 mg) is a novel fibroblast growth factor receptor (FGFR) inhibitor, created by Incyte Corporation. The product was approved in March 2021 and was launched in June 2021 for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. Pemigatinib was shown to selectively inhibit kinase activity of FGFR1～3 (IC₅₀; 0.39～1.2 nM). In cultured cells, pemigatinib inhibited the phosphorylation of FGFR1 and its downstream signals, ERK1/2 and STAT5 in a concentration-dependent manner. Pemigatinib also potently inhibited the growth of various types of cell lines with FGFR 1～3 gene alteration. Pemigatinib was shown to induce concentration-dependent tumor regression in a tumor xenograft model mice in which tumor tissue sections from patients with cholangiocarcinoma (CCA) harboring FGFR2 gene fusions were transplanted. Pemigatinib was well tolerated in Japanese and overseas Phase1 studies (INCB 54828-101 and 202). In the global phase2 study (INCB 54828-202) conducted in CCA patients with FGFR2 gene fusions or rearrangements, significant improvement in the overall response rate was observed. Although several adverse reactions were observed which was based on the mechanism of action of pemigatinib, the safety profile and management of the adverse reactions were favorable. Pemigatinib is expected to contribute to second-line drug treatment after failure of standard therapies in biliary tract cancer.

Nippon Yakurigaku Zasshi

Pharmacological characteristics and clinical study results of Pemigatinib (Pemazyre Tablets), a selective fibroblast growth factor receptor (FGFR) inhibitor

作者: Kabu, Koki ; Takei, Satoko ; Harada, Takashi ; Kitazawa, Kazuya ; Kondo, Midori

Pemigatinib (Pemazyre Tablets 4.5 mg) is a novel fibroblast growth factor receptor (FGFR) inhibitor, created by Incyte Corporation.The product was approved in March 2021 and was launched in June 2021 for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.Pemigatinib was shown to selectively inhibit kinase activity of FGFR1~3 (IC₅₀; 0.39~1.2 nM).In cultured cells, pemigatinib inhibited the phosphorylation of FGFR1 and its downstream signals, ERK1/2 and STAT5 in a concentration-dependent manner.Pemigatinib also potently inhibited the growth of various types of cell lines with FGFR 1~3 gene alteration.Pemigatinib was shown to induce concentration-dependent tumor regression in a tumor xenograft model mice in which tumor tissue sections from patients with cholangiocarcinoma (CCA) harboring FGFR2 gene fusions were transplanted.Pemigatinib was well tolerated in Japanese and overseas Phase1 studies (INCB 54828-101 and 202).In the global phase2 study (INCB 54828-202) conducted in CCA patients with FGFR2 gene fusions or rearrangements, significant improvement in the overall response rate was observedAlthough several adverse reactions were observed which was based on the mechanism of action of pemigatinib, the safety profile and management of the adverse reactions were favorable.Pemigatinib is expected to contribute to second-line drug treatment after failure of standard therapies in biliary tract cancer.

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管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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药物(靶点)	适应症	全球最高研发状态

Axatilimab-csfr ( CSF-1R )	慢性移植物抗宿主病更多	临床3期
帕萨利司 ( PI3Kδ )	滤泡性淋巴瘤更多	临床2期
INCB-086550 ( PDL1 )	晚期恶性实体瘤更多	终止
Povorcitinib ( JAK1 )	-	无进展
瑞弗利单抗 ( PD-1 )	晚期恶性实体瘤更多	无进展